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REGULATORY AFFAIRS (Global) - Associate Director
For a worldwide biopharmaceutical company. LOCATION: The SF, CA area. Compensation: to 180K range + bonus + stock options. Responsible for leading and managing regulatory activities in line within FDA and ICH guidelines. Prepares submissions, including clinical trial applications, NDA’s for the US and in countries such as Latin America, Africa, and Asia. REQUIREMENTS: MS or PhD. 10+ years of relevant experience in global regulatory affairs Knowledge of regulatory requirements including FDA and ICH guidelines An understanding of global and regional trends for assigned territories. Strong leadership and management skills in directing regulatory teams.
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